MAUDE Adverse Event Report: ZEST ANCHORS, LLC LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI); ENDOSSEOUS DENTAL IMPLANT

Model Number	07452
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Non-integration.Primary stability could not be achieved.
Event or Problem Description
Non-integration.Primary stability could not be achieved.

• Brand Name: LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad 92010
• Manufacturer (Section G): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad CA 92010
• Manufacturer Contact: amie toor ; 2875 loker ave east; carlsbad, CA 92010 ; 7608712036
• MDR Report Key: 13064082
• Report Number: 2023950-2021-00465
• Device Sequence Number: 5823667
• Product Code: DZE
• UDI-Device Identifier: 00840481101502
• UDI-Public: 00840481101502
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 07452
• Device Catalogue Number: N/A
• Device Lot Number: L1QLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown